Teveten HCT

INDICATIONS

TEVETEN® HCT is indicated for the treatment of hypertension. It may be used
alone or in combination with other antihypertensives such as calcium channel
blockers. This fixed dose combination is not indicated for initial therapy (see
DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

The usual recommended starting dose of eprosartan is 600 mg once daily when
used as monotherapy in patients who are not volume-depleted (see WARNINGS,
Hypotension in Volume- and/or Salt-Depleted Patients). Eprosartan can be
administered once or twice daily and total daily doses ranging from 400 mg to
800 mg. There is limited experience with doses beyond 800 mg/day. If the antihypertensive
effect measured at trough using once-daily monotherapy dosing is inadequate,
a twice-a-day regimen at the same total daily dose or an increase in dose may
give a more satisfactory response. Achievement of maximum blood pressure reduction
in most patients may take 2 to 3 weeks. Hydrochlorothiazide is effective in
doses of 12.5 mg to 50 mg once daily. To minimize dose-independent side effects,
it is usually appropriate to begin combination therapy only after a patient
has failed to achieve the desired effect with monotherapy. The side effects
(see WARNINGS) of eprosartan are generally rare and apparently independent
of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily
hypokalemia) and dose-independent (e.g., pancreatitis) phenomena, the former
much more common than the latter. Therapy with any combination of eprosartan
and hydrochlorothiazide will be associated with both sets of dose-independent
side effects.

Replacement Therapy

TEVETEN® HCT may be substituted for the individual components. The usual
recommended dose of TEVETEN® HCT is 600 mg/12.5 mg once daily when used
as combination therapy in patients who are not volume-depleted (see WARNINGS,
Hypotension in Volume-and/or Salt-Depleted Patients). If the antihypertensive
effect measured at trough using TEVETEN® HCT 600/12.5 mg is inadequate,
patients may be titrated to TEVETEN® HCT 600/25 mg once daily. Higher doses
have not been studied in combination. Achievement of maximum blood pressure
reduction in most patients may take 2 to 3 weeks. If the patient under treatment
with TEVETEN® HCT requires additional blood pressure control at trough,
or to maintain a twice a day dosing schedule of monotherapy, 300 mg TEVETEN®
may be added as evening dose. TEVETEN® HCT may be used in combination with
other antihypertensive agents such as calcium channel blockers if additional
blood-pressure-lowering effect is required. Discontinuation of treatment with
eprosartan does not lead to a rapid rebound increase in blood pressure.

Elderly, Hepatically Impaired or Renally Impaired Patients: No
initial dosing adjustment is generally necessary for elderly or hepatically
impaired patients or those with renal impairment. No initial dosing adjustment
is generally necessary in patients with moderate and severe renal impairment
with maximum dose not exceeding 600 mg daily. TEVETEN® HCT may be taken
with or without food.

HOW SUPPLIED

TEVETEN® HCT is available as film-coated, capsule-shaped tablets, supplied
as bottles of 100 tablets as follows: